Laparoscopic Surgery or Standard Surgery in Treating Patients With Endometrial Cancer or Cancer of the Uterus

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00002706
First received: November 1, 1999
Last updated: May 27, 2015
Last verified: May 2015
  Purpose

This randomized phase III trial is studying laparoscopic surgery to see how well it works compared to standard surgery in treating patients with endometrial cancer or cancer of the uterus. Laparoscopic surgery is a less invasive type of surgery for cancer of the uterus and may have fewer side effects and improve recovery. It is not known whether laparoscopic surgery is more effective than standard surgery in treating endometrial cancer.


Condition Intervention Phase
Endometrial Adenocarcinoma
Stage I Uterine Corpus Cancer
Stage I Uterine Sarcoma
Stage II Uterine Corpus Cancer
Stage II Uterine Sarcoma
Procedure: Laparoscopic Surgery
Other: Quality-of-Life Assessment
Procedure: Therapeutic Conventional Surgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Randomized Clinical Trial of Laparoscopic Pelvic and Para-Aortic Node Sampling With Vaginal Hysterectomy and BSO Versus Open Laparotomy With Pelvic and Para-Aortic Node Sampling and Abdominal Hysterectomy and BSO in Endometrial Adenocarcinoma and Uterine Sarcoma, Clinical Stage I, IIA, Grade I, II, III

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Duration of disease-free interval [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    The usual logrank test or a proportional hazards model will be used to assess the equality of the hazard rates between the surgical procedures.

  • Frequency of aborting LAVH in order to perform an TAH/BSO [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Frequency of major surgical complications, graded according to the NCI CTC and classified as either less than grade 2 or grade 2 or worse [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
  • Length of hospitalization following surgery [ Time Frame: From the date of surgery to the date of discharge, assessed up to 5 years ] [ Designated as safety issue: No ]
    A proportional odds model will be used to estimate the treatment difference while adjusting for potential confounding factors.

  • Self assessed quality of life scores as measured by FACT-G, Physical Function Subscale from the MOS SF-36, Wisconsin Brief Pain Inventory, Fear of Relapse/Recurrence scale, and Personal Appearance scale [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]

Enrollment: 2616
Study Start Date: April 1996
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients undergo vaginal hysterectomy and BSO via laparoscopy.
Procedure: Laparoscopic Surgery
Undergo vaginal hysterectomy and BSO via laparoscopy
Other Names:
  • Laparoscopic Surgery
  • laparoscopic-assisted resection
  • laparoscopy-assisted surgery
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
Active Comparator: Arm II
Patients undergo total abdominal hysterectomy and BSO via conventional laparotomy.
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
Procedure: Therapeutic Conventional Surgery
Undergo total abdominal hysterectomy and BSO via conventional laparotomy

Detailed Description:

OBJECTIVES:

I. Compare the incidence of surgical complications, peri-operative morbidity, and mortality in patients with stage I or IIa, grade I-III endometrial cancer or uterine cancer undergoing surgical staging through laparoscopic assisted vaginal hysterectomy vs total abdominal hysterectomy.

II. Compare the length of hospital stay after surgery in patients receiving these treatments.

III. Compare the quality of life of patients receiving these treatments. IV. Compare the incidence and location of disease recurrence in patients receiving these treatments.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo vaginal hysterectomy and bilateral salpingo-oophorectomy (BSO) via laparoscopy.

ARM II: Patients undergo total abdominal hysterectomy and BSO via conventional laparotomy.

Patients in both arms also undergo pelvic and para-aortic lymph node sampling. Quality of life is assessed at baseline, at 1, 3, and 6 weeks, and then at 6 months.

Patients are followed at 6 weeks, every 3 months for 2 years, and then every 6 months for 3 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of stage I or IIA, grade I-III endometrial adenocarcinoma or uterine sarcoma
  • Must be considered a candidate for surgery
  • No contraindication to laparoscopy
  • No clinical or chest x-ray evidence of metastasis beyond the uterine corpus or macroscopic involvement of the endocervix
  • Performance status - GOG 0-3
  • WBC at least 3,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Bilirubin no greater than 1.5 times normal
  • SGOT no greater than 3 times normal
  • Creatinine no greater than 2.0 mg/dL
  • Prior malignancy allowed if no current evidence of disease
  • Not pregnant
  • No prior pelvic or abdominal radiotherapy
  • See Disease Characteristics
  • No prior retroperitoneal surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002706

Locations
United States, Pennsylvania
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: Joan Walker Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00002706     History of Changes
Other Study ID Numbers: GOG-LAP2, NCI-2012-02237, CDR0000064513, GOG-LAP2, GOG-LAP2, U10CA027469
Study First Received: November 1, 1999
Last Updated: May 27, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Uterine Neoplasms
Genital Neoplasms, Female
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Connective and Soft Tissue
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Uterine Diseases
Adenocarcinoma
Sarcoma
Carcinoma
Genital Diseases, Female

ClinicalTrials.gov processed this record on June 30, 2015